1. Clinical trial Data Programming & Management
What can ExeCTU do for you?

2. What we can help you with?
Recruitment
Randomisation
Electronic Data Capture
Data management
Clinical trial Data Programming & Management

3. Clinical trial Data Programming & Management
SPA Case Study
Clinical trial Data Programming & Management

4. Recruitment Module – SPA Example
Not Eligible
Initial Screening
Eligible
Declined Consent
Consent Visit
Consented
Withdrawn
Baseline Visit
In Study
Data flow diagram of the SPA visits
1st Follow up Visit
2nd Follow up Visit
Clinical trial Data Programming & Management

5. Recruitment Module – Participant Details
Step 1: Add Participant details
Step 2: New participant listed
Step 3: Click on the Recruitment button to show Recruitment Details page.
Step
Clinical trial Data Programming & Management

6. Recruitment Module – Initial Screening
Status includes: Pending, eligible, not eligible, declined, lost
Action includes: Pending screening interview, arranged…, completed…, contacted…, participant unreachable
Contact Method: Phone, post, , face-to-face
Contact method: phone, , post, face to face
All configurable
Clinical trial Data Programming & Management

7. Recruitment Module – Consent Visit
Status: Consented, Declined Consent, Lost
Action: Pending Consent visit, arranged…., consent completed etc..
Clinical trial Data Programming & Management

8. Recruitment Module – In Study Visits
1st Follow up – participant withdrawn and status set to Out of Study for that participant.
Changed status to withdrawn and enter reasons
Clinical trial Data Programming & Management

9. Clinical trial Data Programming & Management
Randomisation
Pure random 
Static block
Dynamic block
Minimisation
The database randomization system comprises the following validated methods;  
Pure random – participants are allocated amongst the arms via die roll values. This can also be used for the first N participants before switching to one of the below methods if required. 
Static block – participants are allocated progressively via a pre-set but randomly generated sequence list, e.g. AABBABABABBABAABBABABBAA. 
Dynamic block – as above, but the sequence list is generated dynamically in batches and appended to as allocation progresses. 
Minimisation – participants are distributed randomly amongst treatment arms dynamically with some bias based on pre-set stratifications e.g. age, gender.
Minimization Reference: Testing A Dynamic Randomization Algorithm, Donna E. Levy & Emily A. Blood, Dana-Farber Cancer Institute’
Which are applied to the system via the following workflow (customisable); 
·         First the minimum amount of participant information would be entered (this is configurable from just an anonymous identifier and the stratification values [if performing minimised randomisation], to full details [name, address, demographics, study specific data, etc.] with participant consent). 
·         Once this data is entered, the participant is randomised and the user is provided with their study identifier (the pattern of which is fully configurable), and their allocation arm. 
·         As mentioned above, all workflow actions and details are recorded in the database for auditing. 
Clinical trial Data Programming & Management

10. Electronic Data Capture
Bespoke Case Report Form
Tele-Form - paper scanning system
Systems validation (levels)
Enterprise Electronic Data Capture System (out to tender)
Show screenshots of
Field validation double data entry
Double Data Entry
Tele-Form
Explain the characteristics and advantages of the Enterprise EDC systems
Clinical trial Data Programming & Management

11. What is Systems Validation?
“Computerized system validation is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.” (Wikipedia)
Clinical trial Data Programming & Management

12. Clinical trial Data Programming & Management
The system does exactly what it is designed to do in a consistent and reproducible manner
Clinical trial Data Programming & Management

13. Clinical trial Data Programming & Management
Why bother?
• It is a requirement for CTIMPS - "MHRA deficiency reporting trends show that failure to perform Computerised System Validation is classed as a Major Observation". • It is a recommendation for GCP - "Systems with procedures that assure the quality of every aspect of the trial should be implemented". • It is best practice -"Doing things properly saves time, reduces errors and the chance of harming research, or people".
Get quote for CTIMPs from MHRA
Clinical trial Data Programming & Management

14. What does it mean for you?
Formal process 
User requirements
User acceptance testing
Sign off
Change management
Faster Development
Peace of mind, avoiding breeches and unnecessary amendments
Does exactly what is says on the tin!
...And proof for your paper!
Clinical trial Data Programming & Management

15. How much ExeCTU can do you?
Clinical trial Data Programming & Management

16. Clinical trial Data Programming & Management
CTU Data Services
Clinical trial Data Programming & Management

17. Clinical trial Data Programming & Management
Data Management
Working with data outside of programming tasks
Some R/Stats data tasks for export & analysis
Data Security & Risk Analysis
Data Management Plan
Meta Analysis
Data storage
Co-ordination in obtaining datasets
Data Cleaning
Collaboration with the Statistical team
Clinical trial Data Programming & Management

18. INTERPRESS-IPD Case Study
Clinical trial Data Programming & Management

19. INTERPRESS-IPD
The Inter-arm blood pressure difference individual patient data collaborations

20. INTERPRESS-IPD
The project seeks to develop a new prognostic model for cardiovascular risk estimation that includes IAD

21. Clinical trial Data Programming & Management
INTERPRESS-IPD
Is an NIHR Research for Patient Benefit Programme
Is an International collaboration Study
Combines individual patient data (IPD) from IAD studies
Cleaning Data
One large dataset
Meta-analysis
perform cross-sectional analyses to describe the epidemiology of IAD in the dataset.
Lead investigators contributing datasets will be acknowledged in all relevant publications.
Clinical trial Data Programming & Management

22. Clinical trial Data Programming & Management
INTERPRESS-IPD
Clinical trial Data Programming & Management

23. Clinical trial Data Programming & Management
Where we’re heading...
Enterprise EDC tool frees up programmer time for:
Comprehensive Document Management System – SharePoint
SOPS, Policies & Work Instructions 
Review & Approval Workflows
Electronic Trial Master Files
Electronic Archiving
Advanced Recruitment & Randomisation modules
Systems Integration & Big Data
Statistical Programming
Advanced STATA / SPSS R
Clinical trial Data Programming & Management

24. Clinical trial Data Programming & Management
CTU data team
Clinical trial Data Programming & Management